{"id":152,"date":"2016-06-21T11:33:27","date_gmt":"2016-06-21T16:33:27","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/ohra\/?page_id=152"},"modified":"2024-06-24T14:37:39","modified_gmt":"2024-06-24T18:37:39","slug":"audits-for-research-oversight","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/ohra\/audits-for-research-oversight\/","title":{"rendered":"OHRA Research Quality Program (RQP) Oversight Activities \u00a0"},"content":{"rendered":"

The Human Research Protection Program (HRPP) is responsible for evaluating and improving the conduct of research it oversees to protect the safety of participants and the reliability or validity of study data. Consistent with this responsibility, the RQP may perform a targeted audit or a quality assurance (QA) review of any human research study being conducted at Boston Medical Center\/Boston University Medical Campus or at another site when any member of the faculty and\/or staff of BMC or BUMC is engaged in the research.<\/span>\u00a0<\/span><\/p>\n

Routine Quality Assurance (QA) Reviews<\/span><\/b>\u00a0<\/span><\/p>\n

QA reviews<\/span><\/a> are performed to ensure that the rights and welfare of study participants are protected. QA reviews of new and ongoing research studies ensure that IRB-approved research is conducted in compliance with applicable federal and state regulations, BMC\/BUMC HRPP institutional policies, policies of the IRB of record (if ceded), and other guidance.\u00a0<\/span>\u00a0<\/span><\/p>\n

Additional goals of a routine QA review are as follows:<\/span>\u00a0<\/span><\/p>\n

    \n
  1. Provide study teams with practical, targeted education on best practices based in Good Clinical Practice (GCP).\u00a0<\/span>\u00a0<\/span><\/li>\n
  2. I<\/span>dentify and <\/span>help study teams <\/span>correct potential problems with study conduct, documentation, or process, including problems arising from IRB noncompliance.<\/span>\u00a0<\/span><\/li>\n<\/ol>\n
      <\/ol>\n

      Studies are selected for routine QA reviews based on one or more of the following characteristics:<\/span>\u00a0<\/span><\/p>\n